BEUDAMED
    61 results · 11ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    COMPLETE MOISTUREPLUS MULTIPURPOSE SOLUTION, Formula 9451X; (A) Fourteen US Product Numbers distributed under the COMPLETE MOISTUREPLUS MULTIPURPOSE SOLUTION brand include: 90104 (MoisturePLUS, 12 oz ), 90105 (MoisturePLUS, 2 X 12 oz), 90106 (Complete MoisturePLUS Lens Comfort Pack), 90168 (Complete MoisturePLUS 2 oz Starter Kit + Lens Case), 90169TR (Complete MoisturePLUS, 2 X 16 oz, TRAY), 90170 (Complete MoisturePLUS, 4 oz + Lens Case), 93184 (Active Pack, Complete MoisturePLUS 2 oz & B-N-C 5m1 + Lens Case), 93185 (Complete MoisturePLUS, 12 oz, BEAUTIFUL EYES PROMO), 93186 (Complete MoisturePLUS, 2 X 12 oz, BEAUTIFUL EYE PROMO), 93187 (Complete MoisturePLUS, 2 X 16 oz, BEAUTIFUL EYES PROMO), 93220 (Rejuvenate Kit -contains Complete MoisturePLUS 90174), 93221 (Complete MoisturePLUS, 12 oz + Blink Sample), 93280 (Complete Starter Kit -2 oz Complete MoisturePLUS + Lens Case), 93341 (Complete MoisturePLUS, 4 oz); (B) The same formula (9451X) was sold in (1)Canada (Product Numbers:90113EC, 90175QW, 90176EC, 90177EC, 90187EC & 90197EC), (2)Europe (Product Numbers:90086DF, 90086FC, 90086SA, 90089AX, 90089FP, 90089GB, 90089NR, 90090EQ, 90090GM, 90090RR, 90090RY, 90091EG, 90091GB, 90091GM, 90091KZ, 90091NR, 90091RH, 9009SA, 90096AX, 90096EJ, 90096EQ, 90096EW, 90096FL, 90096FP, 90096GB, 90096GM, 90096LM, 90096RW, 90096RY, 90096SA, 90109FM, 90110EW, 90110FC, 90110FL, 90110KK, 90110KKD, 90115AX, 90115EW, 90115FP, 90115GB, 90115GM, 90115KH, 90117FP, 90117RH, 90118RR, 90119GM, 90119RH, 90124XQ, 90157KK, 90157KKD, 93099EQ, 93099RW, 93136LM, 93137LM, 93365GB & 93365NR) , (3)China (Product Numbers:90281CH, 90282CH, 90283CH, 93095CH, 93191CH, 93262CH, 93283CH, 93404CH, 93407CH, 93416CH & 93464CH) & (4)Various Asia Pacific countries (to include Hong Kong, Australia, New Zealand, Korea, Vietnam, Singapore, India, Indonesia, Sri Lanka, Taiwan, Malaysia, Pakistan and the Philippines) under Product Numbers:90104, 90190ED, 90192ED, 90193ED, 90194ED, 90195ED, 90228ED, 90281AS, 90281KO, 90282AS, 90282KO, 90283AS, 90283KO, 90283UT, 93126AS, 93126KO, 93126UT, 93233UT, 93262AS, 93375AS, 93376AS, 93377AS, 93378AS, 93378AS, 93379AS & 93447AS

    FDA Recall
    Terminated ·Advanced Medical Optics, Inc.·Product code LPN·May 25, 2007

    O.B. PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OKV·July 10, 2015

    O.B. PACK HOSPITAL 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OKV·July 10, 2015

    PREMIUM O.B. PACK CUSTOMED 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OKV·July 10, 2015

    O.B. PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OKV·July 10, 2015

    O.B. PACK 4/CS REV. Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OHD·July 10, 2015

    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz

    FDA Recall
    Terminated ·LivaNova USA·Product code DWC·April 20, 2018

    O.B. Pack, Catalog number 900-012. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OKV·October 8, 2014

    O.B. Pack, Catalog number 900-645. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OKV·October 8, 2014

    Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B¿2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·September 2, 2015

    AC Powered hospital adjustable bed.

    FDA Enforcement
    Class II ·Terminated·Umano Medical, Inc.·June 10, 2020

    EVIS EXERA III Bronchovideoscope

    FDA Enforcement
    Class II ·Terminated·Aizu Olympus Co., Ltd.·August 31, 2022

    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·June 20, 2018

    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·June 20, 2018

    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·June 20, 2018

    Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.

    FDA Enforcement
    Class II ·Terminated·Sheffield Pharmaceuticals, LLC·July 8, 2015

    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·August 13, 2014

    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·August 13, 2014

    B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health Inc.·May 27, 2020

    O.B. Pack, Catalog number 900-645. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·December 10, 2014